US Compounding Recalls Betamethasone Vials Due to Sterility Concerns
US Compounding Inc is recalling 5,514 vials of Betamethasone Combo PF 2 mL due to deficient practices that may impact sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a sterile injection product where sterility assurance is compromised is categorized as Severe (Score 4) due to the significant risk of infection or injury.
Plain-English summary
US Compounding Inc is recalling 5,514 vials of Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL Multi-Dose Vial. The product is a prescription-only medication intended for intramuscular and regional injection, compounded by US Compounding Pharmacy in Conway, Arkansas. The recall is nationwide.
The recall was initiated due to a lack of assurance of sterility. The firm identified deficient practices that may have an impact on sterility assurance for all sterile preparations within their expiry dates. Specific lot numbers and beyond-use dates are listed in the recall documentation.
Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or pharmacist for further instructions. The recall covers specific lots with beyond-use dates ranging from September 2015 to January 2016.
The recalled product
- Product
- Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-02
- Manufacturer
- US Compounding Inc
- Category
- Drug — Sterile Injectable
- Affected units
- 5,514
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Numbers: 20150206@41 BUD: 11/28/2015
- 20151603@58 BUD: 9/12/2015
- 20152007@43 BUD: 1/16/2016
- 20152104@41 BUD: 10/18/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 59 products in this recall →Related recalls
Same manufacturer · US Compounding Inc
See all →- LowUS Compounding Recalls Succinylcholine Chloride Injection Due to Labeling Error
FDA (Drugs) · 2021-01-20
- LowUS Compounding Recalls Neostigmine Methylsulfate Syringes Due to Missing Labels
FDA (Drugs) · 2021-01-06
- SevereUS Compounding Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-02-27
- ModerateUS Compounding Recalls LET Gel 4% Syringes Due to Missing Lot and Expiration Dates
FDA (Drugs) · 2019-02-20
- SevereUS Compounding Recalls Docusate Oral Syringes Due to B. cepacia Contamination
FDA (Drugs) · 2016-12-28
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29